Fianna Fáil Spokesperson on Primary Care & Community Health Services John Brassil has urged the government to ensure that a Bill, which would improve the availability of orphan drugs for rare diseases in the Irish system, progresses through the Oireachtas without delay.

The Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2018 seeks to reform the HSE’s current reimbursement process by establishing a unique process for assessing an orphan drug for reimbursement in Ireland.

He was speaking after the Head of the National Centre for Pharmacoeconomics (NCPE) Prof. Michael Barry confirmed earlier today that the HSE budget for new drugs for 2019 has almost been spent, less than two months into the year.

Deputy Brassil explained, “Ireland is consistently behind the curve when it comes to accessing new and life-changing drugs for people suffering with rare diseases, and this is mostly down to the HSE’s current reimbursement process, which is not fit for purpose. This process needs to be modified to include a unique reimbursement process for assessing orphan drugs.

“The fact that the budget for 2019 is already spent less than three months into the year further highlights the HSE’s lack of progress on biosimilar products, where hundreds of millions of euro is available in savings. The HSE has failed to avail of these savings to date.

“At the moment, orphan and rare drugs are assessed under the same guidelines and procedures as standard drugs – despite the clear differences between the two. Rare, high tech drugs will naturally treat an extremely low patient population. To measure their effectiveness using the same metric as the one used for common conditions will naturally cause a disparity. Other EU countries have adapted their processes for this very reason; we need to do the same.

“Spinraza has been one of the more high profile drugs which has caught the public’s attention, mainly because the families of children suffering with rare neuromuscular disorders have been campaigning so effectively. But they should not have to do that. They, and many others, suffering from rare conditions should be able to access the medication they need.

“There is no one solution which will guarantee access to high tech medicines, however our Bill addresses a clear blockage in that process by moving from a quantitative to a qualitative analysis of the impact and benefit of orphan and rare drugs”, concluded Deputy Brassil.